Digital Therapeutic

Software-based intervention that delivers evidence-based therapy to prevent, manage, or treat a disease.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

Definition

Digital therapeutics deliver therapeutic interventions - typically through software - driven by high-quality clinical evidence. Many are regulated as SaMD and cleared through 510(k) or De Novo pathways.

What this means in practice

Reimbursement remains the chief commercial challenge. The PDURS HCPCS framework and select state Medicaid programs have begun establishing payment paths.

Primary references

3 sources

Link health: 3 verified· last checked 2026-05-09

Digital Therapeutics Alliance·1AdvaMed·1MedTech Europe·1

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On this term

Category: Market Segments
Acronym: DTx
Sources: 3
Updated: 5/5/2026

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Learn in 60 seconds

Software-based intervention that delivers evidence-based therapy to prevent, manage, or treat a disease.

·Reimbursement remains the chief commercial challenge.
·The PDURS HCPCS framework and select state Medicaid programs have begun establishing payment paths.
·Many are regulated as SaMD and cleared through 510(k) or De Novo pathways.

Remember this

Software-based intervention that delivers evidence-based therapy to prevent, manage, or treat a disease.

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